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Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors

This study is currently recruiting participants.
Verified November 2010 by University Hospital Birmingham NHS Foundation Trust
Sponsor:
Information provided by:
University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01028703
First received: December 8, 2009
Last updated: December 1, 2010
Last verified: November 2010
History of Changes
  Purpose

Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the arteries and heart.

Hypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is associated with long term adverse cardiac and vascular effects which include:

  1. Increased arterial stiffness and left ventricular mass
  2. Abnormalities in left ventricular systolic and diastolic function
  3. Increased oxidative stress, inflammation and collagen turnover

Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • Left ventricular mass as measured by CMR and Echocardiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Arterial stiffness as measured by pulse wave velocity [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aortic compliance measured by cardiac magnetic resonance imaging [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Left ventricular systolic and diastolic elastance measured by echocardiography; [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Oxidative stress, inflammation and collagen turnover measured by blood assays of plasma renin, aldosterone, high sensitivity C-reactive protein (hsCRP), procollagen type III aminoterminal peptide (PIIINP) and C-telopeptide for type I collagen (CITP). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Donors
110 will be "cases" that undergo uninephrectomy
Controls
110 "controls"

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Renal outpatient clinic

Criteria

Inclusion Criteria:

  • Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust

Current nationally set Exclusion Criteria:

  • Diabetes mellitus
  • Atrial fibrillation
  • Left ventricular dysfunction (ejection fraction <40% on transthoracic echocardiography)
  • History of cardiovascular or pulmonary disease
  • Evidence of hypertensive end-organ damage.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028703

Locations
United Kingdom
University Hospital Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TT
Contact: Jonathan N Townend, BSc (Hons) MBChB MD FRCP FESC     +44 121 697 8476     john.townend@uhb.nhs.uk    
Sub-Investigator: William E Moody, BMedSc MBChB MRCP            
Principal Investigator: Jonathan N Townend, BSc MBChB MD FRCP FESC            
Sub-Investigator: Richard P Steeds, MA MD FRCP            
Sub-Investigator: Charles J Ferro, BSc MBChB FRCP MD            
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Investigators
Principal Investigator: Jonathan N Townend Univeristy Hospital Birmingham NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Jonathan N Townend, University of Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01028703     History of Changes
Other Study ID Numbers: RKK3922
Study First Received: December 8, 2009
Last Updated: December 1, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham NHS Foundation Trust:
Chronic kidney disease
left ventricular dysfunction
diastolic dysfunction
hypertension

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013